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Bimzelx (Bimekizumab) is a humanized monoclonal IgG1 antibody that is designed to selectively inhibit both interleukin 17A (IL-17A) and interleukin 17F (IL-17F), two key cytokines driving inflammatory processes.
Lead Product(s): Bimekizumab
Therapeutic Area: Immunology Product Name: Bimzelx
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 23, 2022
Details:
Translational data from Phase 2 study of Vyvgart (efgartigimod) in pemphigus further demonstrate argenx’s scientific leadership in FcRn biology, providing new insights into pathophysiology of autoimmune skin blistering diseases and potential role of FcRn blockade.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 19, 2022
Details:
Phase 3 RAISE and MycarinG studies in generalized myasthenia gravis (gMG) show RA-101495 (zilucoplan) and rozanolixizumab improve gMG-specific outcomes with consistent statistical significance and clinical relevance.
Lead Product(s): Zilucoplan
Therapeutic Area: Immunology Product Name: RA-101495
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 10, 2022
Details:
Study met primary endpoint, demonstrating a higher proportion of sustained platelet response with VYVGART (efgartigimod alfa-fcab) treatment compared to placebo (p=0.0316); responders observed across patient types regardless of prior therapy or disease severity.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: Vyvgart
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 05, 2022
Details:
The results show zilucoplan was well-tolerated and no major unexpected safety findings were identified compared to earlier zilucoplan studies. The incidence of serious treatment emergent adverse events (TEAEs) in the zilucoplan and placebo treatment arms was similar.
Lead Product(s): Zilucoplan
Therapeutic Area: Immunology Product Name: RA101495
Highest Development Status: Phase III Product Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 04, 2022
Details:
BE COMPLETE is the second positive Phase 3 study for Bimzelx (bimekizumab) directly inhibit interleukin in active psoriatic arthritis, meeting its primary and all ranked secondary endpoints with statistically significant and clinically meaningful results.
Lead Product(s): Bimekizumab
Therapeutic Area: Immunology Product Name: Bimzelx
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 21, 2022
Details:
BE MOBILE 1 is the second Phase 3 study of bimekizumab across the spectrum of axial spondyloarthritis to report positive results, and together with the first study in ankylosing spondylitis, supports the potential of bimekizumab across the full disease spectrum.
Lead Product(s): Bimekizumab
Therapeutic Area: Immunology Product Name: Bimzelx
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 18, 2022
Details:
Positive top-line results are based on BE MOBILE 2 Phase 3 trial, evaluating the efficacy and safety of Bimzelx (bimekizumab) in the treatment of patients with AAS. The trial met the primary endpoint and all ranked secondary endpoints with statistical significance.
Lead Product(s): Bimekizumab
Therapeutic Area: Immunology Product Name: Bimzelx
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 16, 2021
Details:
Data support the selective inhibition of IL-17F in addition to IL-17A in the treatment of ankylosing spondylitis and psoriatic arthritis, and demonstrate the potential of bimekizumab to provide durable clinical responses for people living with chronic conditions.
Lead Product(s): Bimekizumab
Therapeutic Area: Immunology Product Name: UCB4940
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 05, 2021
Details:
Phase 3 ADAPT trial of efgartigimod, an FcRn antagonist, for the treatment of adults living with generalized myasthenia gravis (gMG). Efgartigimod is currently under review with the FDA for the treatment of gMG.
Lead Product(s): Efgartigimod
Therapeutic Area: Immunology Product Name: ARGX-113
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 16, 2021
